RPS has a Wiki!

Regulated Product Submissions (RPS) now has a Wiki (or more accurately, it’s part of the overall HL7 Wiki).

To get there, go to Main Page HL7 Wiki. You will have to log in, but you can use the following credentials for read only access:

user name: wiki
password: wikiwiki

(You must create a user name and password if you want to contribute.)

Once you get there, click on the Regulated Product Submissions link in the Projects category.

There is not much in the main area, but following the RPS R2 Project link at that point will give you access to write-ups on Scope and Domain Analysis, as well as a link to business scenarios. Look for information and updates to be posted fairly often.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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